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FDA approves AI algorithm to help detect wrist fractures

May 25, 2018

The Food and Drug Administration has cleared new computer-aided detection and diagnosis software that uses an artificial intelligence algorithm to analyze X-ray images to detect wrist fractures in adult patients.

The OsteoDetect software from Imagen Technologies, which was reviewed through the De Novo premarket regulatory pathway for low to moderate risk devices, analyzes wrist radiographs using machine learning techniques to identify and highlight regions of distal radius fracture—a common type of wrist fracture—to aid detection and diagnosis.

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